Patient-specific Reconstruction Plate for Segmental Mandibular Defects

Patient-specific Reconstruction Plate for Alloplastic Bridging of Segmental Mandibular Defects. A Clinical and Radiographic Study.

The mandible's horseshoe-shaped anatomy makes the reconstruction of segmental defects a challenging procedure. Conventional reconstruction typically relies on alloplastic plates to bridge bony stumps; however, these require extensive intraoperative bending, often resulting in imperfect adaptation, press-to-contact fixation, and residual stresses that increase the risk of hardware fatigue and fracture. Recent advances in computer-aided design and manufacturing (CAD/CAM) and virtual surgical planning (VSP) have improved precision in maxillofacial reconstruction. Patient-Specific Reconstruction Plates (PSRP), developed from virtual planning and patient-specific anatomical data, offer a bespoke contour adaptation, predictable screw positioning, and elimination of press-fit deformation. This customization improves alignment, mechanical stability, and long-term outcomes.

Study Overview

• Status: Recruiting
• Conditions: Mandibular Reconstruction; Mandibular Reconstruction* / Methods; Mandibular Resection
• Intervention / Treatment: Device: Patient specific reconstruction plate

Detailed Description

The study aims to assess the clinical performance and morbidity rate of computer-guided PSRP in the management of mandibular segmental defects.

This prospective interventional clinical trial will be conducted on a total of 14 patients with a segmental mandibular defect, recruited from Alexandria University Teaching Hospital. All patients will be reconstructed using a PSRP alloplastic bridging plate, utilizing a preoperative virtual surgical planning and design. Patients will be evaluated clinically for the rate of morbidity and range of mandibular excursions. Furthermore, postoperative radiographic 3D analysis will evaluate the accuracy of the computer-guided procedure.

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yehia A El-Mahallawy., PhD; Phone Number: 002 +201007217014.; Email: yehia.el-mahallawy@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria Governorate
    • Alexandria, Alexandria Governorate, Egypt, 21523
      • Recruiting
      • Faculty of Dentistry, Alexandria University
      • Contact: Yehia A El-Mahallawy, PhD; Phone Number: +201007217014; Email: yehia.el-mahallawy@alexu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with a segmental mandibular continuity defect, not involving the condyle.
2. Patients suffering from benign, locally invasive or malignant lesions that involving the lower border of the mandible.
3. Patients with recurrent lesions after resection.

4. Patients dealing with osteomyelitis or jaw osteonecrosis that is indicated for sequestrectomy.

   • Stage-III jaw osteonecrosis.

5. Patients with traumatic defects.
6. Patients with post-gunshot mandibular defects.

Exclusion Criteria:

1. Medically compromised patients contradict the operation.
2. Patients with segmental mandibular defects that require condylar process resection
3. Patients with lateral segmental mandibular defects involving the condyle that require reconstruction using an alloplastic total joint.
4. Patients with an active infection at the site of resection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient specific reconstruction plate; patient with mandibular ablation defect managed with patient specific reconstruction plate	Device: Patient specific reconstruction plate; Patient specific reconstruction plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications and degree of morbidity	All patients will be assessed immediately post-operative, at 1 and 3 months. Any complication that arises during the clinical follow-up period will be monitored and reported. Complications include prolonged hospital stay, prolonged drug administration, signs of screw or PSRP loosening, PSRP fracture, wound dehiscence or tissue necrosis, Intra/extraoral PSRP exposure, and fistulae.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Range of Mandibular Excursions	The range of mandibular excursions will be objectively recorded using a caliper measurement during the clinical follow-up periods. The following excursions will be recorded: Intra-Incisal Mouth Opening (I-IMO) Dental Midline Deflection on Opening (DMD-O) Chin Midline Deflection on Opening (CMD-O)	3 months

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: yehia M El-Mahallawy, Phd, Faculty of Dentistry, Alexandria University, Alexandria, Alexandria

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: December 20, 2025
• First Submitted That Met QC Criteria: December 20, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 20, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: surgery; software; computer-assisted; computer-aided design; computer-aided manufacturing; mandibular resection
• Other Study ID Numbers: 20-12-25/PSRP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No